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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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9 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus â… , R130 in patients with advanced bone and soft tissue tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: R130 Treatment Group | Experimental | Every 7-14 days,1-2 ml R130 (concentration of 1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral in patients with relapsed/refractory bone and soft tissue tumors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant oncolytic herpes simplex virus type â… (R130) | Drug | R130, a modified herpes simplex virus-â… (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11 |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of adverse events | To characterize the safety profile of R130 injection in patients with relapsed/refractory bone and soft tissue tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) | Up to 6 months |
| Subject incidence of laboratory abnormalities | Detection of liver and renal function, electrocardiogram, routine blood examination etc | Up to 1 month |
| Systemic Immune Response | Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Assessment for Disease Control Rate | Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST | Every 10 weeks for 12 months |
| Disease Assessment for Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pan Feng, MD | Contact | +8613764868528 | pf@jxyymedtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | China |
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Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
| Every 10 weeks for 12 months |
| Quality of Life Assessment | Evaluate with EORTC QLQ-C30 | Every 6 weeks for 12 months |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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